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Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository (HS PROGRESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04115566
Recruitment Status : Recruiting
First Posted : October 4, 2019
Last Update Posted : June 6, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date September 18, 2019
First Posted Date October 4, 2019
Last Update Posted Date June 6, 2022
Actual Study Start Date August 1, 2020
Estimated Primary Completion Date September 1, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 1, 2019)
Primary Objective [ Time Frame: 2019-2029 ]
The primary aim of this study is to identify clinical and biologic characteristics of hidradenitis suppurativa.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 1, 2019)
Secondary Objective [ Time Frame: 2019-2029 ]
Secondary aims include correlating alterations in clinical and biological characteristics with disease status, and identifying genetic variants that predict disease progression or response to therapy.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository
Official Title Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository
Brief Summary Hidradenitis suppurativa (HS) is a common and debilitating skin disease that is poorly understood and understudied. As a result, little is known about disease prognosis and few effective treatments exist for this condition. This prospective observational cohort study aims to comprehensively characterize the clinical and biological features of HS. The results of this research will provide a basis for the development of an HS clinical classification system and identification of potential treatments for HS.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population HS Patients
Condition Hidradenitis Suppurativa
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 1, 2019)
3000
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2029
Estimated Primary Completion Date September 1, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Male or female ≥ 10 years of age
  2. Diagnosis of HS by a dermatologist or practitioner experienced in making a diagnosis of HS
  3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

1. Inability to give informed consent or unavailability of a parent/guardian who is able and willing to give informed consent.

Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Hannah Balter 415-502-4741 hannah.balter@ucsf.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04115566
Other Study ID Numbers 18-27002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party University of California, San Francisco
Original Responsible Party Haley Naik, University of California, San Francisco, Assistant Professor of Dermatology
Current Study Sponsor University of California, San Francisco
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Haley B Naik, MD, MHSc, FAAD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date June 2022